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Cmc Program Manager Jobs in New York (NOW HIRING)

Knowledge of state, local, and federal programs strongly preferred * Experience in use of Milliman/InterQual criteria * A Care Management certification preferred (i.e. CMC, CCM etc.) * Computer ...

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This program, in which Coming Home is a provider, allows us to augment our case management services ... Case Manager will also participate in the Case Managers Collaborative (CMC), comprised of case ...

... programs strongly preferred โ€ข Experience in use of Milliman/InterQual criteria A Care Management certification preferred (i.e. CMC, CCM etc.) Computer skills essential Core Competencies ...

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Cmc Program Manager information

What is the difference between Cmc Program Manager vs Cmc Project Manager?

AspectCmc Program ManagerCmc Project Manager
CredentialsTypically requires a Bachelor's degree in life sciences, engineering, or related field; often certifications like PMP or PgMPUsually holds a Bachelor's degree in a relevant field; PMP certification is common
Work EnvironmentOversees multiple projects within a program, coordinating cross-project activities in biotech or pharma industriesManages individual projects, focusing on specific deliverables within the CMC scope
Employer & IndustryPharmaceutical, biotech, or life sciences companies managing complex product developmentSimilar industry, often within the same companies, focusing on specific project execution

The Cmc Program Manager oversees multiple related projects, ensuring alignment with strategic goals, while the Cmc Project Manager focuses on executing individual projects within the CMC domain. Both roles require similar credentials and work in the same industry, but differ in scope and responsibilities.

What is a CMC Program Manager?

CMC Program Managers are professionals responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical or biotechnology product development. They coordinate cross-functional teams to ensure that drug development activities related to product formulation, manufacturing, quality, and regulatory submissions are completed on time and within budget. Their role is crucial in advancing products through clinical development to commercialization while ensuring compliance with global regulatory requirements.

What are the key skills and qualifications needed to thrive as a CMC Program Manager?

To thrive as a CMC Program Manager, you need expertise in chemistry, manufacturing, and controls (CMC), project management experience, and an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems, quality management tools, and certifications such as PMP or Six Sigma are highly valued. Strong leadership, cross-functional communication, and problem-solving skills help manage diverse teams and complex projects effectively. These skills ensure the successful development, regulatory compliance, and timely delivery of pharmaceutical products.

What are some typical challenges a CMC Program Manager faces when coordinating cross-functional teams?

A CMC Program Manager often encounters challenges in aligning the goals and timelines of diverse teams such as process development, analytical, regulatory, and manufacturing. Communication gaps and shifting priorities can complicate project execution, especially when managing external partners or contract manufacturing organizations. Proactive stakeholder engagement and clear documentation are essential to ensure that everyone remains on track and regulatory requirements are met. Successfully navigating these complexities is key to advancing products efficiently through the development pipeline.
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Infographic showing various Cmc Program Manager job openings in New York as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 17% Part Time, 1% Temporary, and 4% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Executive Director, Global Program Leader

Legend Biotech US

Somerset, NJ โ€ข On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 3 days ago

New


Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTIยฎ (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.
Legend Biotech is seeking an Executive Director, Global Program Leader as part of the Research & Development team based in Somerset, NJ.
Role Overview
The Executive Director, Global Program Leader (GPL) is a senior strategic leadership role responsible for the overall development, execution, and governance of Legend Biotech's in vivo CAR-T programs.
Reporting directly to the President of R&D, the GPL serves as the single point of accountability for leading cross-functional teams to define and execute integrated global development strategies from IND enabling through clinical proof-of-concept, late-stage development, registration, and lifecycle management. The GPL ensures alignment of program strategy, timelines, resources, and operational execution across Research, Clinical Development, Regulatory Affairs, Translational Sciences, Technical Development, Manufacturing, Commercial, Business Development, and other key functions.
The successful candidate will combine strong scientific and clinical development expertise with exceptional leadership, strategic thinking, and execution capabilities to advance innovative in vivo CAR-T therapies for patients worldwide.
Key Responsibilities
  • Partner closely with Clinical Development and Regulatory Affairs to design efficient development pathways that maximize speed to proof-of-concept, pivotal development, and global approvals.
  • Guide critical regulatory interactions and major health authority milestones.
  • Ensure readiness and alignment for INDs, CTAs, BLA/MAA submissions, and lifecycle management activities.
  • Chair Global Program Teams and provide leadership across all functional areas involved in program execution.
  • Foster effective collaboration among Research, Translational Medicine, Clinical Development, Regulatory Affairs, Biometrics, CMC, Quality, Manufacturing, Commercial, Finance, and Business Development.
  • Drive cross-functional problem-solving and ensure timely resolution of strategic and operational risks.
  • Establish clear governance processes, decision frameworks, and accountability mechanisms.
  • Present program strategies, risks, and recommendations to executive leadership and governance committees.
  • Lead preparation of development scenarios, investment analyses, milestone recommendations, and portfolio reviews.
  • Provide regular updates to senior management on program status, emerging opportunities, and critical risks.
  • Ensure effective risk management and contingency planning throughout development.
  • Represent Legend Biotech in interactions with external partners, collaborators, investigators, key opinion leaders, and other stakeholders.
  • Support business development assessments, diligence activities, and partnership opportunities related to in vivo CAR-T technologies.
  • Serve as a scientific and strategic ambassador for Legend's in vivo CAR-T platform.
  • Build a high-performance, patient-focused, and collaborative program culture.
  • Mentor and develop program management and cross-functional team members.
  • Champion innovation, accountability, and operational excellence across development teams.

Requirements
  • MD, PhD, PharmD, or equivalent advanced scientific or medical degree required.
  • Advanced training in oncology, immunology, cell and gene therapy, hematology, or related disciplines preferred.
  • Minimum 10+ years of biotechnology or pharmaceutical industry experience in drug development.
  • Minimum 5+ years of leadership experience managing complex, global development programs.
  • Demonstrated success advancing biologics, cell therapies, gene therapies, or other advanced therapeutic programs through clinical development.
  • Direct experience leading cross-functional development teams in a matrix environment.
  • Experience supporting global regulatory interactions and major regulatory submissions.
  • Experience in oncology, immunology, cell therapy, gene therapy, or in vivo genetic medicines strongly preferred.
  • Deep understanding of global drug development, clinical development, and registration pathways.
  • Strong knowledge of cell and gene therapy development, including emerging in vivo CAR-T technologies.
  • Exceptional strategic thinking and portfolio management capabilities.
  • Demonstrated ability to influence senior leaders and drive decisions in complex environments.
  • Outstanding communication, presentation, and executive stakeholder management skills.
  • Strong business acumen, financial awareness, and risk-management capabilities.
  • Proven ability to lead diverse global teams and achieve ambitious development goals.
  • Ability to operate effectively in a dynamic, fast-paced biotechnology environment.

#Li-AS1
#Li-Hybrid
The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Pay Range (Base Pay):
$256,073-$336,097 USD
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
Work Authorization & Employment Eligibility
Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
For information related to our privacy notice, please review: Legend Biotech Privacy Notice.